On November 17, 2021, the Drug Enforcement Administration (DEA) issued an Advanced Notice of Proposed Rulemaking (the “Notice”) seeking the public’s help with understanding the “practice, industry, and state regulations of telepharmacy.”

As DEA acknowledges in the Notice, telepharmacy is not a term defined by the Controlled Substances Act or DEA’s regulations. The agency’s current understanding of telepharmacy is that it involves “the provision of pharmacist care by a remote pharmacist, through the use of telecommunications and other technologies, to a patient located at a dispensing site.” DEA further states that the dispensing site is usually a “brick and mortar remote site” or “self-service, automated machines.”

Although DEA has done some of its own diligence, it is asking for your help to further understand telepharmacy.  To that end, the agency has included a list of thirty-nine questions that it would like answered by “state regulatory authorities, national and professional associations, industry, telepharmacy vendors and services, and the general public.”

The Advanced Notice of Proposed Rulemaking process provides the public a unique opportunity to shape DEA regulations. I encourage all stakeholders to take the time and respond to DEA’s questions and/or provide whatever comments or suggestions you think are important for DEA to consider when drafting the regulation.  Feel free to contact me if you need assistance with responding to this Notice.

Submission must be uploaded electronically or postmarked on or before January 16, 2022, or sixty days from the date the Notice is published in the Federal Register.